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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03402828
Other study ID # NIS-PSORIASIS-1379
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2018
Est. completion date May 15, 2020

Study information

Verified date December 2019
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will map actual strategies and focus on patients' and dermatologists' experience with the different topicals used, including unspecified products with and without active drugs.


Recruitment information / eligibility

Status Completed
Enrollment 764
Est. completion date May 15, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients planned to receive topical treatment of any kind to prevent relapse of symptoms - Written informed consent Exclusion Criteria: - Contraindications to selected treatment - Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Any topical drug treatment
Any treatment strategy used to prevent relapse of psoriasis symptoms

Locations

Country Name City State
Russian Federation The State Autonomous Foundation of Public Health "Republic Clinical Dermatovenereological Dispensary" of the Republic of Tatarstan Kazan Tatarstan

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of relapse Length of relapse free period after start of maintenance strategy Up to 52 weeks
Secondary Dermatology Life Quality Index Standard QoL measure within dermatology Up to 52 weeks
Secondary PGA (physician's global assessment of symptoms) 5-point verbal rating scale Up to 52 weeks
Secondary PsGA (patient's global assessment of symptoms) 5-point verbal rating scale Up to 52 weeks
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